PMA P110001S016
- Device
- RX Herculink Elite Renal and Biliary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S016
- Product code
- NIN
- Decision date
- 2021-10-26
- Generic name
- STENT, RENAL
- Approval order statement
- Change to the resin supplier for material used in the inner member subassembly of the RX Herculink Elite Renal and Biliary Stent System.
Current openFDA PMA Record#
- Device
- RX Herculink Elite Renal and Biliary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S016
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2021-10-26
- Decision code
- OK30
- Date received
- 2021-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the resin supplier for material used in the inner member subassembly of the RX Herculink Elite Renal and Biliary Stent System.